Helen Ouyang Studies the Ethics of Compassionate Drug Use

helenouyang-headshotCourtesy of Helen Ouyang

Helen Ouyang

In her June 2016 Harper’s feature “Hashtag Prescription: The Hidden Costs of Crowdsourcing a Cure,” Helen Ouyang tells the story of Josh Hardy, a boy who is very ill with kidney cancer and might benefit from a drug that’s not yet FDA-approved. His mother, Aimee Hardy, leveraging social media to mobilize supporters and advocates, pressures the drug company for “compassionate use.” Should the company manufacturing the drug give it to the boy? As initially presented, the dilemma doesn’t seem to be one at all: It seems obvious that the boy should receive the medicine he needs.

But Ouyang digs deeper and shows that the issue isn’t so black and white. As she details, if a drug given under the auspices of compassionate use should kill a patient, such a tragedy could prevent the drug from ever being considered for FDA approval—and thus prevent future patients from benefiting from the drug (and perhaps also put the company out of business). And if the drug works well in the context of compassionate use, it may set up high expectations that fail to materialize in the formal trials required for FDA approval. Ouyang’s story also opens the question of whether leveraging public pressure with social media is really the best way to decide who can have access to a new drug.

In many cases, compassionate use of a drug doesn’t improve outcomes. Ouyang weaves in the story of another boy, Joey, who was diagnosed with metastatic cancer and whose mother, Kathy Liu, attempted to access an investigational drug. Even though she eventually received the drug, it came too late to save Joey.

Ouyang articulates the complexities of this ethical dilemma by telling the stories of two patients, their parents, the CEO of the drug company, and drug regulators at the FDA. The story does not end with easy answers, but rather illustrates the complexity of the issue that at first, as presented on social media, seemed so black and white.

Here, Ouyang tells TON contributor Viviane Callier the story behind the story.

How did you find this story? Is it that you knew you wanted to write about compassionate use and went out to find sources who could illustrate it? Or did you begin with Josh’s story and expand it to show its broader relevance?

The first story I came across was Joey’s story. Towards the end of his life, his mother, Kathy Liu, had written an op-ed in one of the local Gainesville newspapers. I also came across her Change.org petition. That’s where I first got interested in the topic. I was fascinated by what had happened with Kathy Liu and Joey: mainly, that she was spending the last days of his life trying to get this investigational drug and flying across the country. I really felt for her, and I thought it was a fascinating story—it was almost like a movie in how it played out.

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When I found Joey’s story a couple of years ago, I reached out to his mom. We had emailed a little bit, and she said she was interested in meeting me in Gainesville. Later, when I started to look more into it, I came across the Josh story. The Josh Hardy story was interesting because here was someone who got the investigational drug and actually did well on it, which is incredibly rare. And it was amazing how the parents had used social media to do it, which was pretty new. So I reached out to Aimee Hardy and her husband Todd, and also Ken Moch, the CEO of Chimerix [the company that makes brincidofovir, the experimental drug Aimee Hardy was seeking for Josh], and they were willing to speak with me.

At that point, I pitched the story to Harper’s about Joey, with the Josh story as a secondary story. My editor thought that the Josh story was actually the more interesting one, with the social media context.

How did you get sources—the parents of an ill child, and the CEO of a company accused of only caring about money—to speak with you about such a challenging and emotionally loaded subject?

I think that’s a credit to them. They were amazing people willing to share their stories and let me into their lives. But I think that’s the beauty of long-form journalism—you get the time and the opportunity to spend days with these people and talk to them and get the real in-depth story.

With some of the sources, I started with a phone conversation and then I went out to visit them. I spent two or three days with the Hardy’s at their home in Reedville, Virginia. It was a good chunk of time. Aimee was taking care of Josh and had three other sons, so we needed that time together to get her full perspective. She wasn’t somebody that I would have felt comfortable just calling up and asking a few questions.

I knew there had to be a backstory, and I think you really need to have the time and space to be able to talk to people about that.

Since Josh had gotten the drug, the Hardys had given only a few more interviews, so I’m grateful that they were willing to let me into their lives. It was a little hard hunting them down and finding them to begin with, and then having them get back to me—because they were so busy with Josh. I don’t know if they wanted their story told, but they were very kind and open about it once we met. We still stay in touch.

Ken Moch, the CEO of Chimerix, had been pilloried on social media for his initial unwillingness to release brincidofovir to Josh; and a month after he reversed course and did make the drug available for compassionate use, he was fired from Chimerix. How was it to interview him?

He was great—really introspective. He’d thought about this a lot and struggled through it. I thought he was quite open with me, and I made it pretty clear up front that I wanted to hear the full story and his side of things. So I think that made him more willing to speak with me. And I think coming from a doctor’s perspective, I know the realities of these drug trials, and about the concept of compassionate use, so maybe that made it easier for him to speak with me about it.

I think the important part of long-form journalism is having the time and the opportunity to really sit down with folks and talk to them. I don’t really believe for the most part that he was evil and that he just didn’t want to give Josh the drugs. I knew there had to be a backstory, and I think you really need to have the time and space to be able to talk to people about that. It was easy to see his perspective once I met with him. I also met his wife and heard about his sons. So I knew he was a real human with a family and understood what the Hardy’s were going through.

Did being a doctor help you do the reporting?

Yes, some of the experts—the St. Jude doctorshadn’t talked to media before, and I think it was helpful for them to know that my intention wasn’t to make them look bad or anything like that. It was also helpful because the medical aspects of both of the cases were pretty rare and had a lot of medical terms. Joey’s family actually shared the files of Joey’s medical reports with me. So I think having that background made it a lot easier to interpret some of the documents and the medical terms they were using.

Social media lends itself to a very easy story line, which is that this CEO is evil and this kid is dying. Investigating this piece really let me find out why he was saying no.

The flip side of that is trying to explain things in general terms and also to remind people to not use this technical language and medical jargon, which I can’t quote, when they are talking to me.

How has social media changed or amplified the ethical dilemma in this story? 

The point I was trying to make about social media is: What happens when you let the crowd (people who are not medical) decide who gets drugs? I think it raises really hard questions because we get these Facebook links all the time, [and] people share them or retweet, and they don’t have the opportunity or knowledge to go behind the story and understand why this person isn’t getting the drug.

I think social media lends itself to a very easy story line, which is that this CEO is evil and this kid is dying. Investigating this piece really let me find out why he was saying no, and hopefully let people see that, so that next time they are confronted with this issue, they can think twice about it, or learn about what the real story is behind it.

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Every feature story inevitably leaves a lot of material out—information and interviews that just can’t fit. Who did you speak with who wasn’t included in the final story?

Besides legislators and lots of doctors and researchers, I also spoke to people who mounted social-media campaigns on behalf of families/friends [but] weren’t successful. That was really hard, not to be able to include their stories, as I know it was emotionally difficult for them to speak with me.

I want to emphasize how grateful I am to Harper’s for giving me the space and the freedom to report fully on the issue and to be able to write the story completely. I don’t think the complexity of that story could have came through without them allowing me that. In particular, my editor was really amazing—just an incredible person to work with. He really taught me about how to be mindful of readers—what sticks with them, what’s too complicated, how to be subtle and still get the point across.

When I was writing the story … I really struggled because I felt like I should come out on one or the other side of it.

For example, the editor wanted the readers to come to their own conclusions about the reasons why Josh fared better with social media than Joey did, without directly saying anything, though of course we hinted at why. Also, in the first draft, I had a lot more about Kathy’s grief, which he cut out, and it definitely was the right move to be more subtle with it.

What was the biggest challenge of writing this story?

When I was writing the story, I was having this internal turmoil talking to Aimee and meeting Josh, and then talking to Ken Moch and hearing his perspective. I really struggled because I felt like I should come out on one or the other side of it. Then I realized that’s what makes the story so difficult and also so interestingthat it is so incredibly challenging. There isn’t just one right answer.

 

Viviane CallierCourtesy of Viviane Callier

Viviane Callier

Viviane Callier is a freelance science writer and Science Fellow at the Howard Hughes Medical Institute. She has a PhD in biology from Duke University. Follow her on Twitter @vcallier.

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